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NCT00885430 Clinical Trial

Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Hyponatremia Clinical Trial

Official title:
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00885430
Other study ID # Hookey Pico-Salax Volunteers
Secondary ID
Status Completed
Phase Phase 4
First received April 20, 2009
Last updated September 18, 2015
Start date July 2008
Est. completion date September 2008

Study information
Verified date September 2015
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

- healthy volunteers older than 45

Exclusion Criteria:

- impaired renal function

- congestive heart failure ascites known electrolyte abnormalities

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Pico-Salax
Two sachets of Pico-Salax given 5 hours apart

Locations
Country Name City State
Canada Hotel Dieu Hospital Kingston Ontario

Sponsors (2)
Lead Sponsor Collaborator
Queen's University Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum electrolytes 48 hours Yes
Primary patient hemodynamics 48 hours Yes
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